Long-term outcomes of patients treated with sirolimus-eluting resorbable magnesium scaffolds: Insights from the SHERPA-MAGIC study

• Published in: International journal of cardiology 2023-07, Vol.383, p.1-7
• Main Authors: Pompei, Graziella, Campo, Gianluca, Ruggiero, Rossella, Maffeo, Diego, Sgura, Fabio, Arrotti, Salvatore, Preti, Gerlando, Iannaccone, Mario, Erriquez, Andrea, Biscaglia, Simone, Sganzerla, Paolo, Capecchi, Alessandro, Pignatelli, Gianluca, Dall'Ara, Gianni, Saia, Francesco, Tomassini, Francesco, Rolfo, Cristina, Varbella, Ferdinando, Cerrato, Enrico
• Format: Article
• Language: English
• Subjects: Outcome; Percutaneous coronary intervention; Resorbable magnesium scaffold; Vessel oriented cardiac event
• ISSN: 0167-5273; 1874-1754
• DOI: 10.1016/j.ijcard.2023.04.029

The resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) that has shown conflicting results in previous studies. These findings suggest that patient selection and implantation technique may have an impact on clinical outcomes. This study aimed to investigate the safety and long-term effectiveness of RMS in a narrowly selected population. SHERPA-MAGIC is an investigator-driven, multicenter, prospective, single-arm study that enrolled patients undergoing BRS coronary implantation in 18 Italian centers. The present analysis considered the first 543 enrolled patients treated with RMS, with a minimum follow-up of 1 year. The study protocol included strict criteria for patient selection and standardization of RMS implantation. The primary outcome was the occurrence of the vessel-oriented composite endpoints (VOCE), including cardiac death, target vessel myocardial infarction, and ischemia-driven target vessel revascularization. Overall, 635 vessels were treated. The 1-year cumulative occurrence of VOCE was 22 (3.5%, 95% CI 2.2%–5.2%), which was significantly lower than the prespecified estimation (from 5.5% to 8.5%). At the median follow-up of 3.5 [2.6–4.3] years, there were 3 (0.5%) cardiac deaths, 12 (1.9%) target vessel myocardial infarctions, and 33 (5.2%) ischemia-driven target vessel revascularizations. A total of 37 (5.8%, 95%CI 4.1%–7.9%) VOCEs were detected. Scaffold thrombosis occurred in 4 (0.6%, 95%CI 0.1%–1.6%) cases. Patient-level analysis confirmed the findings of the vessel-level analysis. These results confirm the safety and performance of RMS technology. If confirmed in randomized controlled trials, they may rekindle interest in the use of scaffolds in daily practice. Central illustration summarizing the qualifying criteria for patient and lesion selection and the standardized RMS implantation technique according to SHERPA-MAGIC protocol. In the bottom panel, the main results of the study are listed: the cumulative occurrence of VOCE at 1 year follow-up and at median follow-up; the cumulative occurrence of POCE at median follow-up; the rate of instent restenosis and Scaffold Thrombosis. [Display omitted] •Resorbable magnesium scaffold (RMS) is a second-generation bioresorbable scaffold (BRS) showing conflicting results in first studies.•The long-term clinical outcome of the first 543 patients enrolled in the SHERPA-MAGIC study expands the recent BIOSOLVE-IV findings.•Indeed, the present results confirm the saf